The purpose of this study is to evaluate and compare the effect of two dosing regimens, BID versus TID dosing, of an Exploratory Vehicle (EV) on meibomian gland dysfunction (MGD) in patients with Demodex lid infestation.
This is a prospective, randomized controlled, three-arm, investigator- and interpreter-masked study. This study is intended to compare the effect of two dosing regimens of an exploratory vehicle on meibomian gland dysfunction (MGD) in participants with Demodex lid infestation. Approximately 12 participants will be enrolled in each arm. The administration period will last for approximately 85 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
The Exploratory Vehicle is the vehicle of TP-03 (lotilaner ophthalmic solution, 0.25%)
Shultz Chang Vision
Northridge, California, United States
Vita Eye Clinic
Shelby, North Carolina, United States
Treatment Emergent Adverse Events (TEAEs)
TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term. TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
Time frame: 85 days
Change from baseline in lower lid meibomian gland secretion score
For each of the 15 glands expressed, secretion characteristics will be graded via slit lamp examination on a scale of 0 to 3 (3=clear liquid secretion; 2=cloudy liquid secretion; 1=granularly opaque liquid secretion to inspissated/toothpaste consistency; and 0=no secretion).
Time frame: 85 days
Change from baseline in lid margin erythema.
Erythema of the eyelid margin will be assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe) for the upper and lower eyelids of each eye.
Time frame: 85 days
Change from baseline in tear breakup time assessed via slit lamp
Tear breakup time will be assessed via slit lamp examination and timed in seconds to two significant digits.
Time frame: 85 days
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